FDA Inspection
Inlightened Partners LLCInlightened Partners LLC – FDA Inspection, Nov 26, 2018
Record Details
This FDA Inspection record concerns Inlightened Partners LLC, with an inspection on November 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e746f11b-a48e-42a7-87fd-baba2af2ac5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072548
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Inlightened Partners LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 2, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Inlightened Partners LLC
- FDA Inspection 1013339 - 2017-05-15
- FDA Inspection 898627 - 2014-10-02
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